Gaining the special regulatory status in a prophylactic setting for posoleucel is the most significant yet for the T cell therapy developer.
Allovir has been lifted after posoleucel, its lead off-the-shelf (allogeneic) T-cell therapy to treat and prevent viral diseases, was awarded a third Regenerative Medicine Advanced Therapy (RMAT) designation to potentially speed up approval in the US.
Shares in the US biotech rose 18% after the firm reported that the US Food and Drug Administration granted the...
The news will have a big impact on pandemic preparedness but less immediate financial impact. Tiba Biotech was even “caught off guard” by its inclusion in the department’s culling of mRNA vaccine projects under BARDA, as its project was neither a vaccine nor mRNA-based.
Yeytuo will have remaining challenges to PrEP to overcome, while Kisunla’s label reflects dosing titration data from a Phase IIIb study to mitigate ARIA-E.
Pointing to data that show a benefit in reducing viral load and the histological signs of the infection, Memo says its drug, potravitug, could become the first therapy to treat BK polyomavirus in kidney transplant recipients.
The approval for young children, consistent with the FDA’s new COVID-19 vaccine policy, restricts Spikevax to those with conditions putting them at higher risk.
Deupirfenidone hit its Phase II endpoint but the program remains risky and PureTech’s new Celea Therapeutics will aim to pull in extra funding for its late-stage development.
Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.
Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.
